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"us-food-and-drug-administration"

  • First oral pill for postpartum depression approved by US FDA

    The label carries a boxed warning indicating that Zurzuvae may impair driving and other hazardous activities.
  • Third Covid jab likely for highly vulnerable patients

    Recently USFDA gave its nod for the use of Pfizer-BioNTech and Moderna Covid vaccines as additional dose on certain immunocompromised individuals
  • US FDA denies emergency use approval for Covaxin

    The FDA recommended Ocugen to "pursue a Biologics Licence Application (BLA) submission instead of an EUA application" and "requested additional information and data".
  • Glenmark gets USFDA approval for Theophylline ER tablets

    The company said the tablet is the bioequivalent and therapeutically equivalent to the Theophylline extended-release tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Limited.
  • Hyderabad hospital saves life with US FDA-approved non surgical pump technology

    The team performed percutaneous intervention for more than 5 hours by placing a novel percutaneous LV assist device-Impella CP-prior to the procedure
  • Covid jabs for kids: Pfizer to seek approval in Sep

    By early next week, the company is expected to get FDA approval for emergency use of its vaccine in children 12 to 15 years old.
  • Study identifies possible Covid drugs

    The study, published in the journal Cell Reports, screened thousands of existing drugs and drug-like molecules for their ability to inhibit the replication of the Covid-19-causing coronavirus, SARS-CoV-2.
  • US Food and Drug Administration authorises Amazon’s Covid-19 test kit

    Amazon plans to use the real-time RT-PCR Test for detecting SARS-CoV-2 as part of the company's overall preparedness and response programme.
  • US FDA approves emergency use of J&J Covid-19 vaccine

    The authorisation allows the vaccine to be distributed in the US for use in individuals 18 years of age and older, the FDA said on Saturday.
  • Aurobindo Pharma gets nod for generic capsules

    The company has received final approval from USFDA to manufacture and market Droxidopa capsules in the strengths of 100 mg, 200 mg and 300 mg
  • Indian drug firms recall various products in US market

    As per the USFDA, Marksans Pharma is recalling close to six lakh bottles of diabetes drug Metformin Hydrochloride extended-release tablets in strengths of 500 mg and 750 mg in the US market
  • USFDA issues 13 observations to Lupin

    Lupin said it does not believe that the observations will have an impact on disruption of supplies or the existing revenues from operations of this facility
  • This device uses Apple Watch to address nightmare disorder

    The device targets adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD), the FDA said on Friday.

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